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UNITARY PATENT

In 2012 Member States and the European Parliament agreed on the "patent package" - a legislative initiative consisting of two...

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On page 11 we report the UK Supreme Court decision in the case of Human Genome Sciences v Eli Lilly. The Supreme Court upheld the industrial applicability of the novel cytokine Neutrokine-α and upheld the claims to the novel polynucleotide sequence and the novel polypeptide, but remitted the case to the Court of Appeal to consider the sufficiency of the more commercially important claim, which was to the downstream products, i.e. the isolated antibodies that bind to Neutrokine-α. The question mark over this claim was that there are many, probably millions, of antibodies to Neutrokine-α. Some will bind well and some less so. They can all be made and isolated. Was the disclosure sufficient to support a claim of this scope?

Eli Lilly argued that the claim must be interpreted as being limited to just those antibodies that have a valuable use, e.g. as a pharmaceutical or diagnostic agent, and that the specification did not disclose how to identify such antibodies without undue effort, so the claim was insufficient. This attack was dismissed (Eli Lilly v Human Genome Sciences [2012] EWCA Civ 1185, 5 Sept 2012). The Court of Appeal found that there was no "undue effort to make and identify specific antibodies to Neutrokine-α at the priority date" and dismissed the Eli Lilly arguments stating firstly that at the "level of generality" of the patent, all the claimed antibodies have a use in that they bind to Neutrokine-α, and secondly that as a matter of claim construction, it was wrong to read into the claim a limitation to those antibodies having a valuable use.

Eli Lilly attempted to rely on Pharmacia v Merck [2002] RPC 41, in which a wide class of compounds was claimed, all of which could be made, but not all of which had the promised pharmaceutical activity. In that case the claim was invalid for insufficiency. The Court of Appeal distinguished over Pharmacia on the grounds that it was more limited at its level of generality (using the expression familiar from Biogen v Medeva [1997] RPC 1 at pp 48-49) than Neutrokine-α and its antibodies. In any case, the Court of Appeal said, todayPharmacia might be decided a different way or for a different reason (viz. that the claim included within its scope many compounds for which there was no technical contribution and, by contrast, HGS had made a technical contribution - a class of antigens susceptible to industrial application).

Comment
Some may call the claim to the antibodies to be a "reach-through" claim, although that term was not used by the Court of Appeal. The EPO has introduced a new Guideline (Guideline F-III, 9) on the subject of reach-through claims, which it defines as claims directed to a chemical compound (or the use of that compound) defined only in functional terms with regard to the technical effect it exerts on a molecule such as a polypetide, a protein, a receptor or an enzyme. The Guideline says that it is "both reasonable and imperative to limit the subject-matter of the claims to the actual contribution to the art". The Guideline cautions that it would be an undue burden to isolate and characterize all potential compounds, without any effective pointer to their identity. An applicant cannot patent what has not yet been invented. A claim is insufficient if the specification merely constitutes an invitation for the skilled person to perform a research programme.

It is interesting to note that two key findings of fact were relied upon by the UK Court of Appeal. Firstly, it was found that the technical contribution of the reach-through claim was simply a product which binds to Neutrokine-α. Secondly, it was found that it did not require undue effort to make and identify specific antibodies to Neutrokine-α at the priority date. The decision by the UK Court of Appeal therefore appears to take account of the factors in the new EPO Guideline. Given that the Human Genome Sciences claim was allowed by the EPO following appeal to a Technical Board of Appeal, it is perhaps not surprising that the UK Courts came to the same conclusion concerning validity.

Reach-through claims are not allowable in the US in light of the requirements for credible utility, support in the written description, and enablement. This was highlighted in the case of University of Rochester v. G.D. Searle & Co., ([2004] Fed Cir. 358 F.3d 916, 13 Feb 2004) in which the Court of Appeals for the Federal Circuit found the patent in question to be invalid for failing to comply with the written description and enablement requirements.

In Europe, this case indicates that reach-through claims to compounds which did not exist at the time of drafting may potentially be valid, depending on the specific facts of the case. Further, as discussed in our article on page 11 with regard to the Supreme Court decision on industrial applicability, the exact content of the specification is important in determining the validity of the claims. We therefore recommend that any European patent application in this technical area is reviewed by a European patent attorney prior to filing to check for compliance with European requirements.

The decisions in this case offer encouragement for applicants who wish to apply for patent protection of early stage research in Europe. The possibility for obtaining this type of protection may be particularly attractive to applicants from countries, such as the United States, where reach-through claims are unallowable.